Intravenous catheter apparatus with safety function and pressure controlled valve element

ABSTRACT

The invention relates to an intravenous catheter apparatus comprising: a catheter hub arranged at a proximal end of a catheter tube, the catheter hub having an inner surface defining a chamber; a needle defining an axial direction and having a needle tip, the needle extending through the chamber and the catheter tube when in a ready position; a needle guard slidably arranged on the needle and at least partially received in the chamber when the needle is in the ready position, the needle guard including a base portion and first and second arms extending from the base portion, wherein the first arm is deflected radially outwards by the needle against a restoring force when the needle is in the ready position whereby the needle guard is brought into retaining contact with the catheter hub; and wherein the catheter apparatus includes a valve which separates a distal space arranged in distal direction from the valve from a proximal space arranged on proximal direction from the valve. The invention further provides that the valve opens based on a pressure differential between the pressure prevailing in the distal space and the pressure prevailing in the proximal space.

SUBJECT MATTER OF THE INVENTION

The invention relates to an intravenous catheter apparatus, comprising:a catheter hub arranged at a proximal end of a catheter tube, thecatheter hub having an inner surface defining a chamber; a needledefining an axial direction and having a needle tip, the needleextending through the chamber and the catheter tube when in a readyposition; a needle guard slidably arranged on the needle and at leastpartially received in the chamber when the needle is in the readyposition, the needle guard including a base portion and first and secondarms extending from the base portion, wherein the first arm is deflectedradially outwards by the needle against a restoring force when theneedle is in the ready position whereby the needle guard is brought intoretaining contact with the catheter hub; and wherein the catheterapparatus includes a valve which separates a distal space arranged indistal direction from the valve from a proximal space arranged onproximal direction from the valve.

RELATED ART

An intravenous catheter apparatus of this kind is generally known. Theneedle guard serves to prevent a person handling the intravenouscatheter apparatus from accidentally coming into contact with the needletip after placement of the catheter tube in and subsequent removal ofthe needle from a patient's vein. Thereby, the intravenous catheterapparatus helps to avoid unwanted transmission of blood borne diseases.

Moreover, blood reflux into central line and other types of intravenouscatheters can lead to intraluminal thrombosis, creating a full orpartial occlusion of the IV access device. Such occlusions can interferewith IV therapy, provide a nutrient-rich area for pathogenic bacteria,or be detached from the catheter, leading to venous thrombosis. Even incases where intraluminal thrombosis does not lead to further healthcomplications, such a condition requires the replacement of thecatheter, a procedure which can be both time consuming and lead toinjury at the removal site and the new introduction site.

Flow valves for intravenous medical devices are already known fromdifferent prior art documents, e.g. US 2009/0264832 A1, WO 90/00071 A1,EP 1 656 179 A1 or WO 2004/082757 A1. However, the flow valves knownfrom these documents are relatively complicated in their structure anddifficult to manufacture. Moreover, these documents do not include anyhint on safety features including a needle guard.

Moreover, document EP 1 545 681 A1 describes a safety IV catheter havinga valve arrangement. However, this valve arrangement requiresmechanically activated components for actuating the valve. This leads toa complicated structure, which is difficult to manufacture and assembleand which does not provide a reliable function.

OBJECT OF THE INVENTION

It is an object of the present invention to provide an intravenouscatheter apparatus which provides better protection against accidentalpricking by the needle tip and which is inexpensive to manufacture atthe same time.

SUMMARY OF THE INVENTION AND GENERAL DESCRIPTION OPTIONAL FEATURES OFTHE INVENTION

The object is solved by an intravenous catheter apparatus in accordancewith claim 1.

The intravenous catheter apparatus of the invention comprises a catheterhub arranged at a proximal end of a catheter tube and having an innersurface defining a chamber; a needle defining an axial direction andhaving a needle tip, wherein the needle extends through the chamber andthe catheter tube when in a ready position; a needle guard slidablyarranged on the needle and received in the chamber when the needle is inits ready position, the needle guard including a base portion and firstand second arms extending from the base portion, wherein the first armis deflected radially outwards by the needle against a restoring forcewhen the needle is in its ready position whereby the needle guard isbrought into retaining contact with the catheter hub; and retainingmeans for retaining the needle guard in the chamber as long as the firstarm is in its deflected state. The retaining means include a firstdisc-like retaining protrusion provided on the first arm and a retainingdepression formed in the inner surface of the catheter hub and adaptedto receive the retaining protrusion. Moreover, the catheter apparatusincludes a valve which separates a distal space arranged in distaldirection from the valve from a proximal space arranged on proximaldirection from the valve, wherein the valve opens based on a pressuredifferential between the pressure prevailing in the distal space and thepressure prevailing in the proximal space.

In one embodiment, the catheter hub of the intravenous catheterapparatus comprises a main body and extending in an axial direction. Themain body has a distal end and a proximal end. A catheter is attached tothe main body at the distal end of the main body. A port extends fromthe main body in a direction generally perpendicular to the axialdirection. Wings can be provided at the main body opposite from theport. The main body defines a chamber extending from the proximal endtowards the distal end.

By providing the intravenous catheter according to the invention, on theone hand, the safety function provides a safe covering of the needle tipas soon as the needle is in its retracted position. Moreover, thepressure activated valve allows a safe and reliable control of the fluidflow through the catheter apparatus depending on the actual demands forthe therapy of a patient. The pressure activated valve is easy tomanufacture and reliable and easy to handle in practical use.

According to one embodiment of the present invention, the valvecomprises a housing having an first opening and a second opening; and anelastomeric member positioned in the housing, the elastomeric membercomprising a thickness, a continuous peripheral wall projecting from thethickness; and a slit extending through the thickness, a continuousportion of the peripheral wall creating a continuous sealable contactwith the housing and partitioning the housing into an upper section anda lower section, the elastomeric member configured such that uponcreating a pressure differential between the upper section and the lowersection of the housing causes either: (i) the peripheral wall to deflectfrom the housing permitting fluid flow around the elastomeric member; or(ii) the slit to open permitting fluid flow through the elastomericmember.

Moreover, according to a further embodiment of the invention, the valvefurther comprises a support positioned in the housing and surrounded bythe peripheral wall, the support configured to provide fluidcommunication between the first opening and the second opening. Inanother aspect, alone or in combination with any of the previous aspectsmentioned above, the support member is received by or integral with thehousing. In another aspect, alone or in combination with any of theprevious aspects of the first embodiment, the support member comprises aplurality of spaced apart columns arranged about the second opening, thedistal ends of the plurality of columns surrounded by the peripheralwall. In another aspect of the present invention, the support membercomprises an annular wall arranged around the second opening, theannular wall having at least one fluid flow passage providing fluidcommunication between the lower section and the second opening.

In another aspect of the present invention, the second opening comprisesa conduit that extends into the housing and is surrounded the peripheralwall. In another aspect, a portion of the conduit extending into thehousing is of a larger internal diameter than the conduit extendingexternal to the housing.

In another aspect of the present invention, a portion of housing istapered and a distal portion of the peripheral wall tapers in sealablecontact therewith.

In another aspect of the present invention, the upper portion of thehousing comprises an interior wall, the interior wall comprising atleast one recessed channel therein and extending substantially along thelongitudinal axis of the housing, wherein deflection of the peripheralwall from the housing substantially corresponds to the placement of theat least one recessed channel.

In another aspect of the present invention, the housing comprises two ormore components sealably connectable to form a fluid tight assembly.

In another aspect of the present invention, the elastomeric elementcomprises a top surface and a bottom surface separated from the topsurface by the thickness; and the peripheral wall has a secondthickness, and the peripheral wall projects from the bottom surface. Inanother aspect, alone or in combination with any of the previous aspectsof the first embodiment, the second thickness is less than the thicknessbetween the top and bottom surfaces.

In another aspect of the present invention, the elastomeric memberfurther comprises a continuous lateral protrusion along the peripheraledge of the thickness, and the housing is configured with acorresponding recess to receive the continuous lateral protrusion and toprovide a radial stress to the surface of the elastomeric member. Inanother aspect of the present invention, the elastomeric member furthercomprises one or more vertical protrusions on the top surface, thehousing being configured to provide a normal stress to the one or morevertical protrusions. In another aspect of the present invention, thethickness is concave, convex, or concave and convex on opposing sides ofthe thickness.

In another aspect of the present invention, the elastomeric member isannular, oval, cylindrical, hemispherical, or cup-shaped. In anotheraspect, alone or in combination with any of the previous aspects of thefirst embodiment, the elastomeric member is conical frustum-shaped.

In another aspect of the present invention, the top surface of theelastomeric member has one or more fluid channels terminating at theperipheral edge.

In another aspect of the present invention, the slit opens at athreshold pressure greater than a threshold pressure required to deflectthe peripheral wall from the housing.

In another aspect of the present invention, the slit, in combinationwith the first opening and the second opening, is configured to receivean elongated medical device through the housing, in particular theneedle of the catheter apparatus. In another aspect of the presentinvention, the support is configured to receive and/or guide anelongated medical device through the housing, in particular the needleof the catheter apparatus. In another aspect of the present invention,the support in combination with the slit is configured to receive and/orguide an elongated medical device through the housing, in particular theneedle of the catheter apparatus.

According to a further embodiment of the present invention, the housingof the valve is formed as a separate component or wherein the housing ispart of the catheter hub. Thus, it is possible to arrange the valve in aseparate component with a separate housing and to this separatecomponent to the intravenous catheter. As an alternative the valve canbe integrated within the intravenous catheter, e.g. within the catheterhub.

According to one embodiment of the present invention, the catheter hubis formed by at least two components, comprising a distal catheter hubportion holding the catheter tube, and a proximal catheter hub portion,wherein the at least two components are mounted to one another. As amatter of course, further components can be added. The respective distalcatheter hub portion and proximal catheter hub portion may be in directcontact with one another or further components may be arranged inbetween. In this regard, it is possible according to the presentinvention that one of the distal catheter hub portion and the proximalcatheter hub portion includes a female connecting section and whereinthe other of the distal catheter hub portion and the proximal catheterhub portion includes a male connecting section fitting into the femaleconnecting section.

In order to connect the distal catheter hub portion and the proximalcatheter hub portion with one another, the male connecting sectionand/or the female connecting section can be formed with a thread or asnap-fit arrangement fitting into one another. Alternatively or inaddition to providing such arrangements it is possible to glue, weld orotherwise fix these components to one another.

According to another embodiment of the present invention, the proximalcatheter hub portion includes a first proximal catheter hub wall formingsaid chamber. As mentioned above, the chamber is provided for receivingand holding the needle guard in the ready position. The mechanism forholding the needle guard in the ready position and for releasing theneedle guard after its transition in the retracted state is described indetail below.

According to a further embodiment of the present invention regarding thearrangement of the valve, the elastomeric member is arranged in aninternal space formed by the distal catheter hub portion or by theproximal catheter hub portion or by the distal and the proximal catheterhub portion.

Furthermore, in regard to the valve arrangement it is possible accordingto the present invention that the support member is formed as a separateelement or integrally formed either with the distal catheter hub portionor the proximal catheter hub portion. Integrating the support memberallows further simplification of the structure of the present invention.Thereby, the number of parts can be reduced and assembling theintravenous catheter apparatus according to the invention is furtherfacilitated.

In regard to the needle guard, the present invention further providesthat the second arm can be deflected radially inwards when the needletip is received between the arms. Moreover it is possible that the firstand second arms are made of a resilient material. According to apreferred embodiment of the present invention in regard to the needleguard the first and second arms are made of a plastic material.According to a further embodiment of the needle guard, the first andsecond arms are integrally formed with the base portion.

Moreover, the needle guard according to the present invention canfurther provide that the restoring force is created by at least one ofan elastic property of the first arm and an additional tension elementat least partly surrounding the arms.

As a further aspect of the needle guard, the present invention canprovide that the first arm is longer than the second arm. In addition tothat, it is possible that the first arm has a distal end section havingan undercut for catching the needle tip. Moreover, according to anotheraspect of the invention, the distal end section is angled towards thesecond arm and overlaps the second arm.

According to another aspect of the invention, the catheter hub mayfurther comprise retaining means for retaining the needle guard in thechamber as long as the first arm is in its deflected state, theretaining means including a first disc-like retaining protrusionprovided on the first arm and a retaining depression formed in the innersurface and adapted to receive the retaining protrusion. In this regard,according to the invention, it is further possible that the retainingprotrusion has generally parallel proximal and distal faces and/or aconvex, in particular part-cylindrical, peripheral surface.

Moreover, according to a further aspect of the present invention, asecond disk-like retaining protrusion is arranged on the second arm andadapted to engage with the retaining depression.

According to a further aspect of the present invention, wherein theneedle guard comprises a tension element at least partly surrounding thearms in a region proximal of the first retaining protrusion or applyinga linear biasing force biasing the arms together.

According to a further embodiment of the present invention, the needleincludes an opening closed the needle tip, wherein the distance betweenthe needle tip and the opening is arranged such that the opening iscovered by the catheter hub when the needle is in the ready position.Using such an opening, the medical practitioner receives immediatefeedback whether the application to the patient was successful by aso-called flashback feature. The flashback feature provides that a smallamount of blood pours out of the opening into the transparent cathetertube under the pressure of patient such that it becomes immediatelyvisible whether the medical practitioner was successful in introducingthe needle tip into the vein of the patient.

In regard to this aspect of the present invention, it is furtherpossible that the opening is formed by a longitudinal slit extendingwith its longitudinal direction in parallel with or transverse to alongitudinal axis of the needle. Further shapes of the opening are alsopossible. However, forming a longitudinal slit provides an easy andsimple way of manufacturing the opening.

According to a further aspect of the present invention the needleincludes a needle feature close to its needle tip changing thecross-sectional shape of the needle. Such a feature can be anenlargement of the cross section of the needle, like a surrounding bumpor rip formed on the outer circumferential surface of the needle shaftor formed by a local protrusion of added material provided at oneparticular outer circumferential part of the needle shaft. Alternativelyand easier to manufacture, the needle feature can be formed by a localcrimp providing that the needle is locally squeezed and deformed suchthat it has an oval cross-section which does not fit through thecircular opening within the needle guard.

In this regard, the invention may further provide that the needle guardincludes an opening with a predetermined diameter interacting with theneedle feature such that it prevents the retraction of the needle out ofthe needle guard when the needle is in the retracted position. Accordingto this aspect of the invention, it is possible that the opening of theneedle guard interacting with the needle feature is integrally formed inthe needle guard or formed by an a metal or plastic washer. Such anadditional component like a metal or plastic washer can be co-moldedwith the the needle guard during manufacturing.

In a further embodiment, a method of controlling flow direction throughthe intravenous catheter apparatus according to the invention isprovided. The method comprising: creating, in a device comprising thevalve as defined in any of aspects of the first embodiment, a pressuredifferential between the upper section and the lower section of thehousing; causing the peripheral wall to deflect from the housing andpermitting fluid flow around the elastomeric member; or, in thealternative; causing the slit to open permitting fluid aspirationthrough the elastomeric member; wherein fluid flow direction through thedevice is controlled.

In regard to another aspect of this method, the pressure differentialbetween the upper section, i.e. the proximal space, and the lowersection, i.e. the distal space, of the housing is created by a negativepressure applied to the proximal section of the housing or by a positivepressure applied to the distal section of the housing so that the slitpermits fluid flow therethrough. Furthermore, in regard to this method,the pressure differential between the proximal section and the distalsection of the housing is created by a positive pressure applied to theproximal section of the housing so that the peripheral wall permitsfluid flow around the elastomeric member.

In regard to another aspect of this method, the method further comprisesintroducing a flushing solution to the upper portion of the housing viathe first opening; causing, by positive pressure, deflection of theperipheral wall from the housing; urging the flushing solution aroundthe elastomeric member; redirecting fluid flow in the lower section ofthe housing; and cleaning at least a portion of the lower section of thehousing.

In regard to a further aspect of this method, the cleaning furthercomprises preventing thrombus within the device after aspiration ofbiological fluid through the device or preventing bacterial growthwithin the device after aspiration. The method further may furthercomprise preventing reflux within the device.

The valve of the present disclosure, and in particular the intravenouscatheter according to the present invention comprising the valve, reduceor eliminate reflux of blood into the distal tip of a vascular catheter.The valve has, by design, a high injection direction flow rate and ahigh internal fluid mixing, preventing un-flushable fluid volumes whichcould lead to bacterial colonization and catheter related blood streaminfection (CRBSI). These two primary benefits are not readily availablein the valves and devices present in the art.

The presently disclosed valve implemented within the intravenouscatheter according to the present invention h can also be referred to asa “pressure activated valve,” or, alternatively referred to as an“infusion patency valve”. The valve comprises an elastomeric memberconfigured to reside in a housing, the elastomeric member having a slitthrough a thickness, the elastomeric member further having a deflectableperipheral wall in interference contact with the housing interior so asto form a fluid-tight seal and to partition the housing into an upperand lower portion. Each partition having associated therewith an openingfor fluid egress and ingress.

In one aspect, the disclosed valve allows for a low-head pressuredelivery of fluids in one-direction to flow through the valve andopenings the catheter apparatus. This type of fluid delivery isconsistent with both continuous IV therapy and periodic delivery byinjection or IV pump. When fluid, either through an attached Luer orother infusion device, is introduced into the proximal end of a devicecomprising the disclosed patency valve, a pressure differential iscreated between partitions in the housing. The pressure differential, inone state, deflects the peripheral wall surface of the elastomericmember, breaking a fluid-tight seal with the housing. This permits theflow of fluid around the elastomeric member and through this temporaryjunction, and introduces fluid into the other partition of the housingseparated by the elastomeric member.

In one state, e.g., infusion, where there is a positive pressuredifferential formed between the upper and the lower partitions of thehousing, the valve of the present disclosure provides a low valvecracking pressure. In addition to the low cracking pressure, the valveof the present disclosure further provides a low restriction to flow inthe infusion direction (proximal to distal flow direction) which allowsdevices comprising the valve to be used with existing IV infusionsystems. The low, but non-zero, cracking pressure of the valve describedherein still prevents the ingress of air in the infusion direction whenthe valve is near the vertical level of the injection site. This isprovided, among other things, by arranging flowing around theelastomeric member, and configuring the internal design of the housingso as to aid in valve flushability while providing for a high flow rate.

In another state, e.g., aspiration, where there is a negative pressuredifferential formed between the proximal and the distal partitions ofthe housing, the valve of the present disclosure provides a higherthreshold cracking pressure than in the infusion direction. Thisconfiguration of the presently disclosed valve, among other things,prevents reflux of blood into the catheter lumen, typically resultingfrom a transient vacuum caused by the disconnection of a Luer, infusionaccessory, or needle-free access valve. As a result of the design andconfiguration of the presently disclosed valve and devices comprisingsame, the prevention of blood reflux is provided and the risk ofintraluminal thrombosis, and bacterial colonization or infection istherefore, reduced or eliminated. The cracking pressure of the presentlydisclosed valve in the aspiration direction is configured such that itis still low enough to permit the deliberate withdrawal of fluids usinga syringe or vacuum tube, as is conventionally performed.

Another advantage of the presently disclosed valve or devices comprisingsame is the configuration of the valve within the device provides forhigh fluid mixing and/or flushing of blood-contacted surfaces. The fluidvolume and/or velocity in the infusion direction is controlled so as tomaximize fluid mixing in the partitioned space of the device. This highdegree of mixing improves flushing of the valve, limiting dead volumethat could otherwise lead to bacterial colonization from un-flushednutrient-rich infusates.

The valve of the presently disclosed IV catheter apparatus is configuredin one embodiment to be attached to the catheter, and is designed, amongother things, to prevent the reflux of blood or other fluids into thelumen or lumens of the catheter apparatus. Inclusion of the valve,either alone or in a connector, can be used in combination with orintegral with a medical device having a lumen, e.g., a vascularcatheter, and can be configured for coupling with such devices or beconfigured for integration during the manufacture of the catheter, orlater, at the point of use. One advantage of the presently disclosedvalve and devices comprising same is that detachment of an accessingLuer-attached device from a proximal end of a device comprising thepresent valve, or detachment from a needle-free access valve attached tothe proximal end of a device comprising the present valve will not causethe reflux of blood into the central line lumen(s). Moreover, a devicecomprising the present valve will still permit the withdrawal of fluids,such as blood or other biological fluids, through the lumen by anaccessing syringe or vacuum vial (Vacutainer, e.g.).

In one aspect, the valve comprises a housing and an elastomeric member.In another aspect, the valve comprises a housing, and elastomericmember, and a support. The various aspects of the valve are nowdiscussed in reference to exemplary embodiments and/or the accompanyingdrawings.

The housing comprising the valve can comprises a single component or beof a multi-component configuration of the IV catheter apparatus. In oneaspect, the housing comprises an upper section and a lower sectionsealably connectable to the upper section to provide a watertightassembly. In another aspect, the housing comprises an upper sectioncomprised of two or more parts that are sealably connectable to thelower section to provide a watertight assembly. The housing can be of aconventional plastic suitable for medical devices such as polycarbonate,polyester, cyclic olefinic copolymer, ABS, and the like.

The elastomeric member is configured to partition the housing into anupper and lower section. Generally, the elastomeric member can beannular, oval, cylindrical, hemispherical, cup-shaped or conicalfrustum-shaped. In one aspect, the elastomeric member can be cup-shapedor conical frustum-shaped with an internal cavity formed between itsbase and its surface. In one aspect, a horizontal or convex/concavesurface with a peripheral wall projection from that surface forming acup-shape or a conical frustum-shape can advantageously be used. Theperipheral wall from such construction can be oval or round, or ofanother shape, provided a continuous fluid-tight seal can becooperatively arranged with an interior portion of the housing and aportion of the outer surface of the peripheral wall so as to partitionthe housing into an upper and a lower portion, and provide flowdirection functionality to the valve or the device. The peripheral wallcan taper away from the surface it projects from or project normalthereto. Alternatively or in combination with a taper, the outerdiameter of the peripheral wall and/or the surface it projects from canbe greater than a corresponding inner diameter of the correspondingmating portion of the housing so as to provide the interference and/orfluidic seal to and/or partitioning of the housing. The taper angle ofthe peripheral wall can be greater than the taper of the interior wallof the housing to provide an interference relationship of an amountcapable of facilitating a fluid-tight seal there between and toeffectively partition the housing of the device into at least twosections. Alternatively or in combination with the above, the peripheralwall thickness can be tapered toward its distal end.

In one aspect, the elastomeric member comprises a conical frustum shapehaving a surface, the surface having a top surface and a bottom surfaceseparated from the top surface by a first thickness, and the peripheralwall projecting away from the bottom surface has a second thickness, theperipheral wall forming a cavity that includes the bottom surface. Thesecond thickness can be less than or equal to the first thickness. Thesurfaces can be concave and convex on opposing sides or can be concaveor convex on one side only. The top surface of the elastomeric membercan have one or more fluid channels terminating at its peripheral edge.Other features are described below and in the drawings.

According to another aspect, the elastomeric member comprises one ormore slits through a thickness so as to open upon a pressuredifferential between the upper and lower sections of the housing, whichcan be created for example, by withdrawal of fluid from either distalends of a device comprising the elastomeric member. The slit of theelastomeric member is configured to open at a threshold pressure greaterthan a threshold pressure required to deflect the peripheral wall fromthe housing. The housing is configured such that headspace above theelastomeric member and the inside surface of the upper housing providessufficient clearance for the slit to open. In a first state, the slit isresistant to flow in the proximal to distal flow direction (e.g.,infusion) in one aspect, which, among other things, limits the capacityof the slit to open in this flow direction. However, flow in anotherdirection (e.g., aspiration) is permitted through the slit.

In one aspect, the elastomeric member has a generally flat orconvex/concave top surface, having a conical frustum-shaped cavity thatincludes a bottom surface supported by one or more supports (e.g.,protruding columns or a wall) that project aligned with the longitudinalaxis of housing. The support(s) can be integral with the lower housingor can be placed in position during manufacturing. An interference fitof at least a portion of the elastomeric member is maintained byfeatures on either the upper and/or or lower housings components and/orthe elastomeric member. The elastomeric member may also be secured inplace via an annular fitment or projection with or without saidsupport(s) to position the elastomeric member during manufacturing anddevice use and/or provide a radial compressive stress to the slit (e.g.,to adjust or control the slit cracking pressure). For example, theelastomeric member can comprises a continuous lateral protrusion alongthe peripheral edge of its top conical frustum surface, and the housingcan be configured with a corresponding recess to receive the continuouslateral protrusion and to provide interference and/or a radial stress tothe surface thickness of the elastomeric member. The continuous lateralprotrusion can be of a thickness equal to or less than the thickness ofthe surface. In addition to or in combination with, the elastomericmember can comprise one or more vertical protrusions from its conicalfrustum top surface, the housing being configured and dimensioned toprovide a normal stress to the one or more vertical protrusions forsecuring the elastomeric member during assembly or use.

In one aspect the elastomeric member is part of a valve assembly. Thevalve assembly can be configured for a variety of housing configurationsdesigned for fluid coupling, such as two-way, three-way and four-waycouplings. The valve assembly can comprise the elastomeric member andoptional support configured for introduction into a housing. Theassembly can be configured to adapt to a two-piece housing construct,either having a lower/upper housing, a two-piece housing separated alongthe longitudinal axis, or a combination thereof, e.g., a solid lowerhousing and a two-piece upper housing.

Withdraw of fluids through the infusion patency valve (fluid flow fromin the distal to proximal direction) is restricted below the thresholdcracking pressure of the slit(s) which are formed through the centralaxis of the elastomeric member. The threshold cracking pressure isdesigned to be high enough so that transient vacuum caused by thedisconnection of a Luer, infusion accessory, or attached needle-freeaccess valve, does not open the slit and hence, the valve to flow inthat direction. However, the aspiration flow direction “crackingpressure” is designed to be low enough to permit the deliberate withdrawof fluid by syringe or vacuum tube, if needed. The design of the conicalfrustum-like section of the elastomeric member and its interference withthe conical interior portion of the housing provides for one-way flow offluid, operable in either direction, controlling the fluid flow in thehousing between its openings with leak-free function and ease of use.

The valve and devices configured with this valve can be configured forpassage of a medical device e.g., an introducer such as a guidewire orother medical device. Designs with the present valve can provide for an“over the guidewire” placement or replacement technique and eliminate orprevent bleed-back or air embolisms. In one aspect of the presentdisclosure each of the embodiments are exclusive of spring-actuatedvalve assemblies, or spring-actuated valve assemblies having anintroducer valve within a cavity of the valve housing, or compressionring actuated valve assemblies. Of course, such devices can be used incombination with the presently disclosed valve. The valve embodimentsdisclosed herein eliminate the need for a triple layer design of a slitopening, followed by a hole, followed by another slit opening, forexample. Indeed, in certain aspects, the present disclosure is devoid ofpinching of the elastomeric member between halves of the housing forsupporting the elastomeric member, whereas, instead, a design of theelastomeric member in cooperative relationship with the interior wall ofthe housing is employed. Likewise, the presently disclosed valveembodiments minimize dead space above and below the valve assemblyand/or provides for effective flushing of any such dead space.Furthermore, the present valve embodiments avoid problems common toother configurations of pressure-actuated valves used in medicaldevices, such as: 1) leakage of fluids through “dome-like” septa havingslits for two-way fluid transfer; 2) an inability to gravity feedthrough devices having a slit “trampolined” between walls of a housing;and 3) an inability to effectively flush the inside of the device withvalves designed for two-fluid flow through the slit. The present valve,in contrast, provides for elimination of leakage, the ability to gravityfeed, as well as improved flushing of the inside of the devicecomprising the valve. Moreover, additional advantages of the valve ofthe present disclosure includes the directional control of fluid flowthrough the device via passage either through or around the elastomericmember, the minimization of dead space and/or improved flushingcapability, repeatable guidewire accessibility without failure orproblems generally associated with known valved systems.

The elastomeric member can be fabricated from conventional thermosetrubbers (synthetic and non-synthetic). The elastomeric member isconfigured between the proximal and distal housings duringmanufacturing. The interference between the conical periphery of theelastomeric member and the conical portion of the proximal housing formsa normally closed valve. This interference, among other things, allowslow pressure passage of liquids in one direction.

The design of the pressure activated/patency valve allows for thepassage of a wire or cannula through the central axis of the device.This is helpful for placement of a PICC or CVC catheter, as well as ashort peripheral IV catheter. Thus, the presently disclosed valve canserve to function as a “bloodless start” valve, thereby limitingexposure of blood to the clinician upon placement of the catheter. Uponinsertion, the wire or needle cannula can be removed, the slitautomatically closes upon its removal, and the caregiver is protectedfrom excess exposure of blood. This may also keep the catheter hub morefree of nutrient rich fluid to further protect the patient from possibleinfection of the site. The slit of the elastomeric member, incooperation with the first opening and the second opening of thehousing, can be configured to receive an elongated medical devicethrough the housing. The housing may include a support or an inwardlytapered opening feeding into the second opening is configured to receiveand/or guide an elongated medical device through the housing.

The above valve provides for a method of creating a pressuredifferential between the upper section and the lower section of ahousing comprising the valve presently disclosed. This pressuredifferential causes either the peripheral wall to deflect from thehousing and permitting fluid flow around the elastomeric member, or, inthe alternative, causes the slit to open permitting fluid aspirationthrough the elastomeric member. In this method, fluid flow directionthrough the device is controlled. By way of example, the pressuredifferential between the upper section and the lower section of thehousing is created by a negative pressure applied to the upper sectionof the housing or by a positive pressure applied to the lower section ofthe housing so that the slit permits fluid flow therethrough. In otherexample, the pressure differential between the upper section and thelower section of the housing is created by a positive pressure appliedto the upper section of the housing so that the peripheral wall permitsfluid flow around the elastomeric member.

The method further comprises introducing a flushing solution to theupper portion of the housing via the first opening and causing, bypositive pressure, deflection of the peripheral wall from the housing.This results in the urging the flushing solution around the elastomericmember and under and in the cavity of the conical frustum-shapedelastomeric member, along with the redirecting of fluid flow in thelower section of the housing. This provides cleaning of at least aportion of the lower section of the housing. This cleaning preventsthrombus within the device after aspiration of biological fluid throughthe device and/or prevents bacterial growth within the device afteraspiration.

The upper and lower housings and further components of the intravenouscatheter apparatus of all embodiments herein disclosed may be secured byultrasonic welding, solvent bonding, glue, adhesive, and/or other heator chemical methods known in the art. In at least one aspect of thepresent disclosure, the housing or its subassemblies is designed suchthat the welding process will capture the elastomeric member betweenhousings producing the normally-closed seal. Housings components can beconfigured for snap-fit, gluing, spin welding, solvent welding and thelike.

Any part of elastomeric member and/or the slit of the elastomeric membermay be lubricated. In one aspect, a silicone lubricant may be used.Different lubricants may be used on different surfaces of theelastomeric member. One or more silicone fluid may be compounded intothe elastomeric member during molding.

The housing and/or supports and further components of the intravenouscatheter apparatus can be injection-molded out of a rigid,biocompatible, engineering grade resin such as polycarbonate, cyclicolefinic copolymer (COC or transparent acrylonitrile butadiene styrene(MABS), and the like. Certain configurations of the elastomeric membermay be constructed using a thermoplastic elastomer TPE, which islikewise injection molded. Liquid injection molding (LIM) can be usedfor the elastomeric member and/or to create the valve assembly.Compression molding or rotational compression molding can be used tomanufacture the elastomeric member. Elastomeric materials can be ofsilicone, polyurethane for such molding methods.

In regard to the further features of the IV catheter apparatus, thefollowing is to be mentioned:

The disc-like retaining protrusion has the benefit that it is inengagement along a circular contact surface with the correspondingretaining depression formed in the inner surface of the catheter hub.Differing from IV catheter apparatuses as known from the prior art, thisprovides an engagement between the needle guard and the catheter hubalong a substantial annular portion of the retaining protrusion and theretaining depression which provides a safe and reliable engagementbetween the two components as long as the needle guard is in its readyposition and is to be prevented from being retracted out of the needlehub. Even if the needle guard is rotated within the catheter hub, thissecure engagement between the catheter hub and the needle guard holdsthe needle guard safely within the catheter hub.

Because of a depression being formed in the inner surface of thecatheter hub for retaining the needle guard in the chamber, instead ofe.g. a protrusion, the catheter hub can be manufactured more easily and,thus, at less manufacturing cost, in particular if the catheter hub is aplastic part and e.g. formed by injection molding. At the same time theparticular design of the first retaining protrusion provided on theneedle guard ensures effective engagement of the retaining protrusionwith the retaining depression and, thus, reliable retaining of theneedle guard in the catheter hub. Hence, the risk of premature releaseof the needle guard from the catheter hub during withdrawal of theneedle from the catheter hub and, thus, the risk of accidental prickingby the needle is reduced.

According to a preferred embodiment, the retaining protrusion is ofpart-circular, in particular semi-circular shape. More specifically, theretaining protrusion may have generally parallel proximal and distalfaces and/or a convex, in particular part cylindrical, peripheralsurface.

According to another embodiment, the first retaining protrusion isarranged in the region of a distal end of the first arm.

According to yet another embodiment, a second disk-like retainingprotrusion is arranged on the second arm and adapted to engage with theretaining depression as long as the first arm is in its deflected state.

According to yet another embodiment, the second arm can be deflected,preferably along its entire length, radially inwards when the needle tipis received between the arms, to thereby allow the second retainingprotrusion to disengage from the retaining depression.

According to yet another embodiment, the second retaining protrusion isarranged in the region of a distal end of the second arm. In particular,the second retaining protrusion may be arranged opposite from the firstretaining protrusion.

According to yet another embodiment, the retaining depression is an atleast part annular depression, preferably an annular depression.

According to yet another embodiment, the restoring force is created byat least one of an elastic property of the first arm and a tensionelement. For example, the needle guard may comprise a tension element atleast partly surrounding the arms in a region proximal of the firstretaining protrusion or—instead of surrounding the two arms—biasing thetwo arms by a linear biasing action. Alternatively or additionally, thefirst and second arms can be made of a resilient material.

According to yet another embodiment, the first and second arms are madeof a plastic material. Preferably, the first and second arms areintegrally formed with the base portion also made of a plastic material,e.g. by injection molding.

For the purpose of a simplified and cost-effective production of theneedle guard, the integrated tension element or resilient member may beformed integrally onto the arms, for example, by injection and/or insertmoulding such that the entire needle guard has a unitary structure.

According to yet another embodiment of the present invention theintegrated resilient member or elastic element may comprise a ring likeintegrated form/structure partially or fully surrounding the arms,and/or clamp, bracket, “C” clip or the like surrounding the arms only inpart.

Alternatively or additionally, the base portion and the first and secondarms may be formed from a metal material or combination of materials,such as a different plastic material, a different metal material or adifferent combination of plastic and/or metal materials. For example,one of the arms may be made of a metal material and other one may bemade of plastic material. Likewise, the base portion may be made from ametal material and the arms may be made from a plastic material or viceversa. It is also to be noted that the inner part of the arms whichcontacts the needle shaft can be made from a thermoplastic material suchas TPE, whereas the outer part of the arms may be made from a differentmaterial, for example, a plastic, metal, composite or elastomermaterial, so that the needle guard causes less friction when slidingalong the needle thereby facilitating the withdrawal of the needle.

According to yet another embodiment, the needle comprises an engagementmeans provided at a distance from the needle tip for engaging with theneedle guard and preventing the needle guard from sliding off theneedle. Preferably, the engagement means is formed of by enlargement ofthe radial dimension of the needle in at least one direction as comparedwith a principal profile of the needle. The engagement means can befound by a local crimp, a shoulder, a bulge formed as an annularwidening etc.

According to yet another embodiment, the needle guard comprises astopping element engaging with the engagement means of the needle whenthe needle tip is received between the first and second arms.Preferably, the stopping element defines an axial bore having across-section adapted to the principal profile of the needle but beingsmaller than the enlargement of the needle. Furthermore, the stoppingelement may be made of a material different from the material of thebase portion, in particular of a metal material. The stopping elementmay be of disc-like shape or tubular shape and/or arranged on a distalside of the base portion. It can be fixed in the base portion orsupported in a floating manner on the needle.

A preferred embodiment of the invention will now be described by way ofexample only with reference to the accompanying drawings.

Embodiments of the present disclosure now will be described more fullyhereinafter with reference to the accompanying drawings, in whichembodiments of the present disclosure are shown. This present disclosuremay, however, be embodied in many different forms and should not beconstrued as limited to the embodiments set forth herein. Rather, theseembodiments are provided so that this disclosure will be thorough andcomplete, and will fully convey the scope of the claims to those skilledin the art. Like numbers refer to like elements throughout.

LISTING OF FIGURES

FIG. 1 is a longitudinal view of an intravenous catheter apparatusaccording to the present invention;

FIG. 2 is a longitudinal sectional view of the intravenous catheterapparatus of the present invention;

FIG. 3 is a longitudinal sectional view according to FIG. 2 without aneedle cover;

FIG. 4 is an explosive longitudinal sectional view of the intravenouscatheter apparatus according to the present invention;

FIG. 5 is a longitudinal sectional view of the intravenous catheterapparatus according to the present invention in the retracted state;

FIG. 6 is a perspective explosive view of another embodiment of theintravenous catheter apparatus according to the present invention;

FIG. 7 is a longitudinal sectional view of a needle guard of theintravenous catheter apparatus of FIG. 5 without a tension element;

FIG. 8 is a top view of the needle guard of FIG. 7;

FIG. 9 is a bottom view of the needle guard of FIG. 7; and

FIG. 10 is a front view of a distal end of the needle guard of FIG. 7;

FIG. 11 is a plan view, with sectional plane A-A, of an embodiment of apressure activated valve in accordance with the present disclosure;

FIG. 12 is a top view of FIG. 11 showing sectional planes 14A-14A and14B-14B;

FIG. 13 is an exploded view of the embodiment of FIG. 11;

FIG. 14A and FIG. 14B are cross-sectional views of the embodiment ofFIG. 11 along sectional planes 14A-14A and 14B-14B, respectively;

FIG. 15 is a perspective view of the upper housing of the embodiment ofFIG. 11;

FIG. 16 is a perspective view of the lower housing of the embodiment ofFIG. 11;

FIG. 17A and FIG. 17B are cross-sectional views of the embodiment ofFIG. 11 along sectional planes 14A-14A and 14B-14B, respectively, in afirst state of operation and in a second state of operation,respectively;

FIGS. 18A, 18B, 18C, and 18D are perspective views of the elastomericmember in accordance with embodiments of the present disclosure;

FIG. 19 is a plan view, with sectional planes B-B, of another embodimentof a pressure activated valve in accordance with the present disclosure;

FIG. 20 is a top view of FIG. 11 showing sectional planes 22A-22A and22A-22A;

FIGS. 21A and 21B are an exploded view and exploded sectional view,respectively of the embodiment of FIG. 19;

FIG. 22A and FIG. 22B are cross-sectional views of the embodiment ofFIG. 19 along sectional planes 22A-22A and 22B-22B, respectively;

FIGS. 23A and 23B are a plan view and a perspective view of the lowerhousing, respectively, of the embodiment of FIG. 19;

FIG. 24A and FIG. 24B are cross-sectional views of the embodiment ofFIG. 19 along sectional planes 22A-22A and 22B-22B, respectively, in afirst state of operation and in a second state of operation,respectively;

FIGS. 25A, 25B, and 25C are sectional views of another embodiment of apressure activated valve in accordance with the present disclosure, FIG.25B showing the embodiment of FIG. 25A rotated 90°;

FIG. 26A is a plan view, with sectional plane 26B-26B, of anotherembodiment of a pressure activated valve in accordance with the presentdisclosure;

FIG. 26B is a cross-sectional view along sectional plane 26B-26B, of theembodiment of FIG. 26A;

FIG. 27A is a plan view, with sectional plane 27B-27B, of anotherembodiment of a pressure activated valve in accordance with the presentdisclosure;

FIG. 27B is a cross-sectional view along sectional plane 27B-27B, of theembodiment of FIG. 27A;

FIG. 28A is a plan view, with sectional plane 28B-28B, of anotherembodiment of a pressure activated valve in accordance with the presentdisclosure;

FIG. 28B is a cross-sectional view along sectional plane 28B-28B, of theembodiment of FIG. 28A;

FIG. 29A is a plan view, with sectional plane 29B-29B, of anotherembodiment of a pressure activated valve in accordance with the presentdisclosure;

FIG. 29B is a cross-sectional view along sectional plane 29B-29B, of theembodiment of FIG. 29A

FIG. 30A is a longitudinal sectional view of another embodiment of thepresent invention;

FIG. 30B shows a detail of the needle close to the needle tip accordingto the embodiment of FIG. 30A;

FIG. 31A is a longitudinal sectional view of still another embodiment ofthe present invention; and

FIG. 31B shows a detail of the needle close to the needle tip accordingto the embodiment of FIG. 31A;

FIGS. 32A & 32B are a longitudinal sectional view of still anotherembodiment of the present invention;

DETAILED DESCRIPTION OF EMBODIMENTS

In accordance with the present invention, an intravenous catheterapparatus which provides better protection against accidental prickingby the needle tip and which is inexpensive to manufacture at the sametime is provided is provided. While this invention is susceptible ofembodiments in many different forms, there will be described hereinspecific embodiments with the understanding that the present disclosureis to be considered as an exemplification of the principles of theinvention and is not intended to limit the invention to the embodimentsdetailed herein.

As used herein, the term “proximal” refers to a region of the device ora location on the device which is closest to, for example, a clinicianusing the device. In contrast to this, the term “distal” refers to aregion of the device which is farthest from the clinician, for example,the distal region of a needle will be the region of a needle containingthe needle tip which is to be inserted e.g. into a patient's vein.

Prior to the use of the catheter apparatus, the needle guard is arrangedin the catheter hub near a proximal end of the needle shaft. In thissituation, the needle extends completely through the needle guard,thereby deflecting the first arm of the needle guard outwards, i.e. atan angle to the axial direction, such that the distal wall of the firstarm is supported on the needle shaft. Following the insertion of thecatheter into a patient, the successful venipuncture is ascertained bythe blood visible from the lateral opening provided in the needle.Thereafter, the needle is withdrawn from the catheter tube and theneedle shaft moves through the needle guard while the needle guard isretained in the catheter hub. Once the needle tip passes the transversedistal wall of the needle guard, i.e. such that the needle shaft nolonger supports the distal wall, a restoring force ensures that thefirst arm of the needle guard is moved back into alignment with theaxial direction of the needle guard, so that the needle tip is blockedby the distal wall of the needle guard, i.e. the needle tip is preventedfrom axially projecting out of the needle guard.

Once the needle tip is blocked by the distal wall, the enlargement ofthe needle shaft engages with the stopping element, when the stoppingelement is arranged between the arms, or with the distal side of thebase portion, when the stopping element is arranged in the base portion,to prevent the needle guard from being removed from the needle shaft.The fact that the stopping element is made from a second material whichis harder and less easily distorted than the first material of the baseportion, has the effect that the needle guard is secured moreeffectively on the needle shaft and can be retained even if excessiveexternal force is applied when pulling on the needle, as the enlargementis prevented from being pulled through the base portion of the needleguard due to the stopping element. Hence, it is less likely that theneedle guard is removed from the needle tip accidentally and, as aresult, the needle guard provides a better protection against accidentalpricking and thus increased safety for the person handling the catheterapparatus.

FIGS. 1 and 2 show an intravenous catheter apparatus 10 according to thefirst embodiment of the invention. The intravenous catheter comprises acatheter hub 12 and a catheter tube 13 attached to the catheter hub 12at a distal end of the catheter hub 12. It will be appreciated that theterm ‘proximal’ refers to a position or orientation close to a personhandling the intravenous catheter apparatus whereas the term ‘distal’refers to a position or orientation distant from this person, whereinthe longitudinal direction A of a needle 20 is the reference direction.

A proximal portion 12 ₁ of the catheter hub 12 has an inner surface 14which defines a chamber 16 of generally circular cross-section. Thechamber 16 is located in a proximal section of the catheter hub 12. In adistal region of the chamber 16 the inner surface 14 of the catheter hubis provided with an annular retaining protrusion 18 the function ofwhich will be discussed in more detail further below.

The catheter hub 12 also includes a distal catheter hub portion 12 ₂.The proximal catheter hub portion 12 ₁ is formed at its distal end witha conical female section 15. The distal catheter hub portion 12 ₂ isformed at its proximal and with a conical male section 17. The conicalfemale section 15 and the conical male section 17 are formed withring-shaped protrusions and recesses which are provided to engage intoone another in order to fix the proximal catheter hub portion 121 andthe distal catheter hub portion 12 ₂ to one another in a snap-fitarrangement. The fixation can be supported by additional adhesive orother ways of fixation, e.g. welding. The conical female section 15forms an internal hollow space 19, which will be discussed further inregard to a valve arrangement. This valve arrangement includes anelastomeric element 110.

The needle 20 having distal and proximal ends extends through thechamber 16 of the catheter hub 12 as well as through the catheter tube13. The needle 20 comprises a needle shaft 22 and a needle tip 24 at itsdistal end. A needle hub 26 is attached to the proximal end of theneedle 20. At the proximal end the needle hub 26 has a hollow spacewhich receives a plug 27 having a passage 29 which receives a porousfilter element 31.

The needle 20 defines said axial (longitudinal) direction A and theneedle shaft 22 has a generally constant principal profile, except foran enlargement of the radial dimension of the needle 20 in at least onedirection as compared to the principal profile, which is positioned inthe region of the needle tip 24 and forms an engagement means, that canbe seen in FIG. 4 at reference sign 25. Preferably, the engagement meansis made by crimping of the needle 20. However, it could also be made bywelding, milling, cold heading or expanding of the needle. The functionof the engagement means will be discussed in more detail further below.

FIGS. 1, 2 and 3 show the intravenous catheter apparatus in a conditionprior to use. In this condition prior to use the needle 20 extends allthe way through the chamber 16 of the catheter hub 12 as well as thecatheter tube 13 and the needle tip 24 protrudes from a distal end ofthe catheter tube 13. This position of the needle 20 is also referred toas the ready position in this context. It is to be noted that the needle20 is fixed in its ready position by the needle hub 26 engaging with thecatheter hub 12.

In order to prevent accidental pricking by the needle 20 prior to use ofthe intravenous catheter apparatus, a tubular cover 30 covers thecatheter tube 13 and the portion of the needle 20 extendingtherethrough. A proximal end portion of the cover 30 is removably fixedto a distal end portion of the catheter hub 12.

The intravenous catheter apparatus further comprises a needle guard 32for protecting the needle tip 24 after use of the needle 20, i.e. afterplacement of the catheter tube 13 in and withdrawal of the needle 20from a patient's vein. The needle guard 32 is slidably arranged on theneedle shaft 22 and received in the chamber 16.

FIG. 4 shows an exploded view with the components described above, whichhowever is not a condition of use. This exploded view rather shows theway, how the IV catheter apparatus according to the invention can beassembled.

FIG. 5 shows the IV catheter apparatus according to this embodiment ofthe invention in a retracted condition when the needle is retracted outof the catheter hub 12. In this condition, the needle tip 24 is coveredby the needle guard 32, wherein the needle featured 25 prevents that theneedle guard 32 is removed from the needle in distal direction. Theneedle tip 24 is covered by the needle guard 32. The plug 27 can beremoved from the needle hub 26. The catheter tube 13 may be introducedinto a patient's vein, which is not shown in detail.

FIG. 6 shows the whole arrangement in a further perspective explodedview. It also shows a hollow fixation plug 31 for fixing the cathetertube 13.

As can be seen in more detail in FIGS. 7 to 10, the needle guard 32comprises a tubular base portion 34 and first and second arms 36, 38extending from a distal side of the tubular base portion 34 generally inthe axial direction. The base portion 34 and the arms 36, 38 areintegrally made of a plastic material, for example by injection molding.

The base portion 34 has an axial through-bore 40 for receiving theneedle 20. The throughbore 40 comprises first and second sections 42, 44both having cross-sections that are larger than the principal profile ofthe needle 20, the cross-section of the second section 44 being evenlarger than the cross-section of the first section 42.

A stopping element 46 in the shape of a disk-like plate, such as awasher, is arranged at the distal side of the base portion 34, forexample by insert molding. The stopping element 46 is made of a materialdifferent from the material of the base portion 34, for example of ametal material. The stopping element 46 has an axial bore 48 which isaligned with the through-bore 40 of the base portion 34 and which has across-section which is smaller than that of the through-bore 40 of thebase portion 34. More specifically, the cross-section of the axial bore48 of the stopping element 46 is adapted to the principal profile of theneedle 20 such that the stopping element 46 can slide along the needleshaft 22 with minimum friction. However, a maximum dimension of theaxial bore 48 transverse to the longitudinal direction A is smaller thana maximum dimension of the engagement means provided on the needle 20transverse to the longitudinal direction so as to prevent the engagementmeans from passing through the stopping element 46 and, thus, to preventthe needle guard 32 from sliding off the needle 20.

The first arm 36 of the needle guard 32 is longer than the second arm 38and has a massive distal end section 50 having an undercut 51 forcatching the needle tip 24. The distal end section 50 is angled towardsthe second arm 38 and overlaps with the second arm 38 (FIG. 8). In itsready position the needle 20 extends completely through the needle guard32 (FIG. 7). In this situation the distal end section 50 of the firstarm 38 is supported on the needle shaft 22 thereby deflecting the firstarm 36 radially outwards. In order to facilitate deflection of the firstarm 36, the first arm 36 has a narrowed portion 52 of reducedcross-section approximately in a middle region of the arm 36. Incontrast to the first arm 36 and because of a lack of angled distal endsection, the second arm 38 is not significantly deflected by the needle20 extending through the needle guard 32. Nonetheless, the second arm 38has a similar narrowed portion 54 the reason for which will becomeapparent further below.

Even though the first and second arms 36, 38 have certain elasticproperties, a tension element, for example a rubber band 56 (indicatedby dotted lines in FIGS. 8 and 9), surrounds a distal section of thearms 36, 38 such that deflection of the first arm 36 occurs mainlyagainst a restoring force of the tension element (FIG. 7).

When the needle 20 is withdrawn from the catheter tube 13 afterplacement of the catheter tube 13 in a patient's vein, the needle 20slides through the needle guard 32 until the needle tip 24 passes theangled distal end section 50 of the first arm 36. At this point theangled distal end section 50 is no longer supported on the needle shaft22 and the first arm 36—mainly by force of its own elasticity supportedby the rubber band 56—snaps back into its relaxed state with the angleddistal end section 50 now blocking the needle tip 24. It will beappreciated that the length of the first arm 36 and the distance of theengagement means from the needle tip 24 are adapted to each other suchthat the needle tip 24 received in the needle guard 32 has a minimum ofclearance with respect to axial movement in the needle guard 32.

In order to prevent the needle guard 32 from being prematurely removedfrom the chamber 16 of the catheter hub 12, i.e. before the needle tip24 is covered by the needle guard 32, the first arm 36 is provided witha disc-like first retaining protrusion 58 engaging with the retainingdepression 18 in the inner surface 14 of the catheter hub 14 in thedeflected state of the first arm 36. The first retaining protrusion 58has generally flat proximal and distal faces 60, 62 and a convex, inparticular part-cylindrical, peripheral surface 64 the radius of whichis adapted to the radius of the inner surface 14 of the catheter hub 12in the region of the retaining depression 18. The height of the firstretaining protrusion 58, i.e. its dimension seen in the radialdirection, is adapted such that the first retaining protrusion 58disengages from the retaining depression 18 when the first arm 36 snapsback into its relaxed state.

The second arm 38 is provided with a disc-like second retainingprotrusion 66 which is similar to the first retaining protrusion 58 andwhich extends in a radial direction opposite from the first retainingprotrusion 58. The second retaining protrusion 66 also has generallyparallel proximal and distal faces 60, 62 as well as a convex, inparticular part-cylindrical, peripheral surface 64. The height of thesecond retaining protrusion 66, i.e. its dimension seen in the radialdirection, is adapted such that the retaining protrusion 66 engages withthe retaining depression 18 when the needle 20 is in its ready position.In order to disengage the retaining protrusion 66 from the retainingdepression 18, the second arm 38 can be deflected slightly radiallyinwards towards the needle 20 when the pulling force on the needle 20becomes great enough.

As can be seen from FIG. 1, the axial dimension, i.e. width, of theretaining depression 18 is significantly larger than the axialdimension, i.e. width, of the retaining protrusions 58, 66. For example,the width of the retaining depression 18 can be three to five times thewidth of the retaining protrusions 58, 66, although other ratios arepossible as long as reliable engagement between the retaining depression18 and the retaining protrusions 58, 66 is ensured.

As mentioned above, the IV catheter device also includes a valve. Inorder to explain the structure and the function of the valve, referenceis made to the FIGS. 11 to 29B for different embodiments of the valve,which can be integrated into an IV catheter. The valve can be formedseparately as discussed in the following or integrated in the catheterdevice. Therefore, the valve is described separately as device 100. Asshown above, the valve can be integrated into the catheter hub 12 whichthen forms the housing of the valve with at least two catheter hubportions 12 ₁ and 12 ₂.

Referring now to the Figures, FIG. 11 is a perspective view of a firstembodiment depicting device 100 which forms the valve as a separatecomponent. Device 100 comprises a rigid upper housing 101 for providingconnection to a male Luer fitting, and a rigid lower housing 102, whichprovides for connection to a female Luer fitting. The device has asmooth exterior for patient comfort. Device 100 has a first opening 101a and a second opening 102 a. While first opening 101 a is shown asthreaded, it can be configured smooth without threads. FIG. 12 is topview of device 100 showing sectional planes described further below.

FIG. 13 is an exploded perspective view of device 100 depicting lowerhousing 102, having supports 112, elastomeric member 110 havingperipheral wall 169 projecting from surface 167 towards lower housing102. On surface 167 is slit 117. Upper housing 101 is configured to formfluid tight seal with lower housing 102. Upper housing 101 can beconfigured with threaded female Luer fittings 106, as shown. The lowerhousing can be configured with male luer 107 and surrounding internalthreads 108, as shown.

Referring now to FIGS. 14A and 14B, cross-sectional views, 90° apartrespectively, of first embodiment device 100 in an assembledconfiguration are shown.

FIG. 14A depicts a portion of peripheral wall 169 of elastomeric member110 having an interference fit with the interior wall 111 forming acontinuous seal with the interior wall 111 of upper housing 101.Elastomeric member 110 partitions device 100 into an upper sectioncorresponding to first opening 101 a and lower section corresponding tosecond opening 102 a. Elastomeric member 110 is shown supported bysupports 112. Supports 112 form opening 109 and provide fluidcommunication between lower housing 102 and through second opening 102a. Elastomeric member 110 is shown here as a normally-closed valve, asboth slit 117 and continuous seal with interior wall 111 prevent fluidflow between openings 101 a and 102 a prior to activation of device 100via a pressure differential. The interference fit between elastomericmember 110 and interior wall 111 of the housing can be provided uponsecuring upper housing 101 and lower housing 102 during manufacturinge.g., upon bonding/welding the housings components together, for exampleat weld joint 114. The elastomeric member is supported by supports 112and the elastomeric member is sealed against the interior wall 111 ofthe upper housing. Fluid is able to flow between the supports intoopening 109 and through first opening 101 a. Lower housing 102 includesbase 102 e surrounding projection 102 c which projects from base 102 eas part of second opening 102 a. Surface (or base) 102 e extendsradially outward to tapered wall 102 d. A portion of the outer diameterof tapered wall 102 d is configured for sealable arrangement via weldjoint 114 with an interior diameter of upper housing 101.

FIG. 14B depicts an aspect of the first embodiment whereby fluid channel115 c is provided in interior wall 111 of upper housing 101. As shown,fluid channel 115 c extends generally parallel to the longitudinal axisof device 100 towards lower housing 102. The distal terminus of thelength of fluid channel 115 c (e.g., distal end 115 d) is configured tobe such that at least a portion of peripheral wall 169 (e.g., as shown,distal end 169 a) remains continuously in interference with interiorwall 111. In one embodiment, device 100 can be configured without fluidchannel 115 c (width equal 0).

In one aspect, two or more fluid channels 115 c are provided in interiorwall 111 of upper housing 101. In such an aspect, two fluid channels 115c can be arranged in a parallel configuration with both theircorresponding longitudinal axes substantially aligned with thelongitudinal axis of device 100. In one embodiment, elastomeric memberhas slit 117 formed of a single slit, and the two fluid channels 115 care arranged to be orthogonal with the longitudinal axis of the singleslit 117. In this configuration, during infusion of fluid, and upondeflection of peripheral wall 169, radial forces are applied to surface167 to facilitate maintaining closure of slit 117.

FIG. 15 shows a perspective view of upper housing 101 depicting fluidchannel 115 c, as shown, in fluid communication with first opening 101 aand having a length generally parallel with the longitudinal axis ofupper housing 101. The width of fluid channel 115 c can be chosen to beapproximately any width equal to a number greater than zero and lessthan of one half the maximum internal perimeter length of upper housing101. In one aspect, fluid channel 115 c width is chosen to be less thanthe minimum internal diameter of first opening 101 a so as to facilitatea focused pressure or force (and/or accelerated fluid velocity) onperipheral wall 169 during infusion and/or flushing of device 100. FIG.16 shows a perspective view of lower housing 102 depicting a pluralityof supports 112 arranged about projection 102 c of second opening 102 a.Supports 112 are arranged radially around projection 102 c with spacingtherebetween so as to allow fluid communication between the upperhousing 101 first opening 101 a and lower housing 102 second opening 102a during infusion. Supports 112 can have distal projections 112 cconfigured to contact lower surface of elastomeric member 110 and tominimize shifting of the elastomeric member 110 within the housingduring assembly or use and/or to apply a preload and/or to account forthe stack up of the upper and lower housing components.

FIGS. 17A and 17B are cross-sectional views of device 100 shown in afirst state (e.g., infusion) and a second state (e.g., aspiration),respectively. Arrows A1 and A2 depict fluid flow direction within device100.

With reference to FIG. 17A, in a first state, a pressure differentialbetween the partitioned housing is created upon infusion of fluidthrough first opening 101 a that causes deflection of peripheral wall169 from interior wall 111 of upper housing 101 creating fluid passage115 and allowing fluid communication between the upper portion and lowerportion of device 100 around elastomeric member 110, while maintainingclosure of slit 117, so as to provide directional fluid flow from firstopening 101 a through second opening 102 a. Structures of lower housing102, e.g., tapered wall 102 d and projection 102 c, can provideturbulence and/or fluid flow direction so as to enable effectiveflushing of elastomeric member portions that have been contacted withbodily fluids (e.g., the interior surface of peripheral wall 169).Peripheral wall 169, which in various aspects, provides an oval,cup-like, or conical frustum-shaped (or frustoconical), is configured todeflect and/or flex inward towards the central longitudinal axis ofdevice 100 upon creating a differential in pressure, (for examplethrough the introduction of infusion fluid the opening 101 a) with arelatively low infusion cracking pressure threshold. A relatively lowinfusion cracking pressure threshold is that of approximately 6 to about36 inches H20 (0.2 psig to about 1.3 psig; where the term “about”encompasses±20% of the stated value). Such pressures are obtained, forexample, when an IV bag is raised above the height of an insertion pointin a patient. Unlike existing valves that flow “through” an elastomerseal/valve in both an infusion state and an aspiration state, thepresently disclosed valve is configured to flow “around” the valve in aninfusion state and through the valve in an aspiration state. Theadvantage of this present configuration is that leaking and “reflux”after aspiration is all but eliminated and the desirable ability toeasily infuse fluid via gravity is provided as described with referenceto the exemplary embodiment of FIGS. 17A and 17B.

With reference to FIG. 17B, in a second state, a pressure differentialcreated upon aspiration of fluid through the second opening 102 a causesslit 117 to open whereas distal end 169 a of peripheral wall 169 ismaintained in continuous sealable interference contact with interiorwall 111 of upper housing 101. In one aspect, the slit is configuredsuch that an aspiration pressure threshold is required to allow fluid topass through the slit from second opening 102 a through first opening101 a. In one aspect, the aspiration pressure threshold is considerablyhigher than that of the infusion cracking pressure threshold. In oneaspect the difference between the aspiration pressure threshold and thatof the infusion aspiration threshold is such that the aspirationthreshold cracking pressure is approximately 5 psig greater than that ofthe infusion threshold cracking pressure. This difference in thresholdcracking pressure can range between about 3 psig and about 7 psig,(where “about” encompasses±20% of the value). Configuring the differencein threshold cracking pressures can be accomplished by varying theelastic modulus, thickness and/or thickness variation, taper,cross-linking/cure, and material selection and dimensions of elastomericmember 110 as well as the design and arrangement of slit 117, discussedfurther below. Additional parameters that can be adjusted with regard tocracking pressure thresholds include the number, width, and length offlow channel 115 c and/or internal geometries of upper and lower housingcomponents.

With reference to FIGS. 18A, 18B, 18C, and 18D, variations of theelastomeric member are shown. FIGS. 18A and 18B, depict elastomericmember 110 having a single slit 117 and multislit 117 a configuration.Other slit configurations can be used.

FIGS. 18C and 18D depict modified elastomeric members 110 a and 110 b,respectively, having additional features on the exemplary conicalfrustum-shaped member 110 a, 110 b, namely projections 1100 on surfaceof conical frustum-shaped member 110 a, or one or more channels 1150 inthe surface of conical frustum-shaped member 110 b.

FIG. 18D further depicts an embodiment of the elastomeric member wherein the conical frustum-shaped member 110 b includes a stem 1175 with aconduit (not shown) there through surrounded by peripheral wall 169 c,the conduit configured to surround second opening 102 a or securelysurround projection 102 c of lower housing 101. Stem 1175 can beconfigured as a conduit for fluid communication with opening 102 a andslit 117. In this configuration, stem 1175 necessarily comprises one ormore vertically arranged (with housing longitudinal axis) openings/slitsthere through (not shown) for fluid passage/flushing during infusion,the opening/slits can be configured to respond to a compressive infusionpressure/force and at least to partially open allowing fluid to enteropening 102 a, whereas, during aspiration, the openings/slits, notsubject to the compressive stress, would remain closed to facilitatesubstantially all fluid flow thru opening 102 a, stem 1175, slit 117,upper section of housing and opening 101 a. In this modification of theelastomeric member embodiment described above, all other functionalattributes, as described above for elastomeric member 110, would bemaintained.

With reference to FIG. 19, a second embodiment of the presentlydisclosed valve is shown, depicting a perspective view of device 200,having upper housing 201 with first opening 201 a and lower housing 202.

FIG. 20 depicts a top view of device 200 with sectional planes 22A-22Aand 22B-22B.

FIGS. 21A and 21B depict an exploded view an exploded sectional view,respectively of device 200. Lower housing 202 of device 200 includesannular wall 212. In this exemplary embodiment, annular wall 212provides support to elastomeric member 210, which is surrounded byperipheral wall 269. Annular wall 212 can be integral with lower housing201 as shown, or can be molded separately and arranged in housing duringassembly. Elastomeric member 210 has lateral annular protrusion 218 fromedge of surface 267 configured to be received by recess 218 a withininterior wall 211 of upper housing 201. In addition, elastomeric member210 includes vertical annular projection 2110 from surface 267 forproviding interference upon assembly of upper and lower housingcomponents 201, 202. Surface 267 of elastomeric member 210 includes slit217, which passes through the thickness of surface 267. Differing fromthe previous embodiment, lower housing 202 of device 200 includestapered opening 202 c feeding into second opening 202 a. Tapered opening202 c provides guidance for insertion of medical devices such as guidewires, etc. into smaller diameter second opening 201 a and preventskinking and/or bending of such devices.

Referring now to FIGS. 22A and 22B, cross-sectional views, 90° apart,respectively, of second embodiment device 200 in an assembledconfiguration are shown. FIG. 12A depicts a portion of peripheral wall269 of elastomeric member 210 having an interference fit with theinterior wall 211 forming a continuous seal with the interior wall 211of upper housing 201. Elastomeric member 210 partitions device 200 intoan upper section corresponding to first opening 201 a and lower sectioncorresponding to second opening 202 a. Elastomeric member 210 is shownsupported by annular projection 212 that includes flow passages 209 thatprovide fluid communication between lower housing 202 and through secondopening 202 a. Elastomeric member 210 is shown here as a normally-closedvalve, as both slit 217 and continuous seal with interior wall 211prevent fluid flow between openings 201 a and 202 a prior to activationof device 200 via a pressure differential. The interference fit betweenelastomeric member 210 and interior housing wall 211 can be providedupon securing upper housing 201 and lower housing 202 duringmanufacturing e.g., upon bonding/welding the housings componentstogether, for example at weld joint 214. The peripheral wall 269 ofelastomeric member 210 forms a fluid-type seal with interior wall 211.Fluid is able to flow through annular support 212 at openings 209 andsecond opening 202 a. Lower housing 202 includes surface or base 202 esurrounding annular support 212 which projects from base 202 e as partof second opening 202 a. Surface or base 202 e extends radially outwardto tapered wall 202 d. A portion of the outer diameter of tapered wall202 d is configured for sealable arrangement via weld joint 214 with aninterior diameter of upper housing 201. FIG. 22B depicts an aspect ofthe second embodiment whereby interior diameter of annular support 212tapers inwardly to that of internal diameter of second opening 202 awhich also serves as guiding means for medical devices that may beinserted through the device.

In a manner similar to that of the first embodiment, device 200comprises optional fluid channel 215 c that extends generally parallelto the longitudinal axis of device 200 towards lower housing 202. In oneembodiment, any of the devices herein disclosed can be configuredwithout fluid channel 215 c.

FIG. 23A shows a side view of lower housing 202 depicting annularsupport 212 and passage 209. FIG. 23B is a perspective view of lowerhousing 202 showing annular support 212 and tapered opening 202 ffeeding into second opening 202 a. Annular support 212 can have distalprojections 212 c configured to contact lower surface of elastomericmember 210 and to minimize shifting of the elastomeric member 210 withinthe housing during assembly or use.

Device 200 functions similarly as that of the first embodiment, asdepicted in FIGS. 24A and 24B, which show cross-sectional views ofdevice 200 shown in a first state (e.g., infusion) and a second state(e.g., aspiration), respectively. Arrows BI and B2 depict fluid flowdirection within device 200. With reference to FIG. 24A, in a firststate, a pressure differential is created between the partitionedhousing of device 200 upon infusion of fluid through first opening 201 athat causes deflection of peripheral wall 269 from interior wall 211 ofupper housing 201 creating fluid passage 215 and allowing fluidcommunication between the upper portion and lower portion of device 200around elastomeric member 210, while maintaining closure of slit 217, soas to provide directional fluid flow from first opening 201 a throughsecond opening 202 a. Structures of lower housing 202, e.g., taperedwall 202 d can provide turbulence and/or fluid flow direction so as toenable effective flushing of elastomeric member portions that have beencontacted with bodily fluids (e.g., the interior surface of peripheralwall 269). Peripheral wall 269 is configured to deflect and/or flexinward towards the central longitudinal axis of device 200 upon creatinga differential in pressure, (for example through the introduction ofinfusion fluid the opening 201 a) with a relatively low infusioncracking pressure threshold as previously described for the firstembodiment. With reference to FIG. 24B, in a second state, a pressuredifferential in the partitioned housing is created upon aspiration offluid through the second opening 202 a that causes slit 217 to openwhereas distal edge 269 a of peripheral wall 269 is maintained incontinuous sealable interference contact with interior wall 211 of upperhousing 201. In one aspect, the slit is configured such that anaspiration pressure threshold is required to allow fluid to pass throughthe slit from second opening 202 a through first opening 201 a.

FIGS. 25A and 25B depict a third embodiment device 300 shown configuredwith upper housing 201 and elastomeric member 210 from the secondembodiment device 200, whereas annular support 312 having opening 309 isconfigured so as not to contact the lower surface of elastomeric member210. Support of elastomeric member 210 is provided solely by lateralannular protrusion 218 and interference with recess 218 a as discussedabove. FIG. 15C depicts device 333, which has a modification to thelower housing component of device 300, where annular support 312 iscompletely absent, and surface or base 302 e of lower housing 302′ hasopening 302 c to feed into second opening 302 a.

FIGS. 26A and 26B are a perspective view and cross-sectional view alongsectional plane 26B-26B of a fourth embodiment device 400 showingimplementation of the pressure activated valve with a male luer lockhousing assembly. Tubing 401 a is bonded to tube housing 401, which isjoined to male luer housing 402. Male luer lock hub 402 c is snap fit tolower housing 402. The function and operation of device 400 is that assimilarly described for the previously described embodiments.

FIGS. 27A and 27B are a perspective view and cross-sectional view alongsectional plane 27B-27B, respectively, of a fifth embodiment, device 500assembled with upper housing 201. Device 500 demonstrates how pressureactivated valve can be integrated directly into a vascular catheter hub502. Catheter 502 a can be a peripheral IV catheter, a PICC, a CVC, orthe like. As shown above and discussed in regard to FIGS. 1 to 9, the IVcatheter according to the present invention is additionally providedwith a needle guard for preventing accidental needle pricking.

FIGS. 28A and 28B are a perspective view and cross-sectional view alongsectional plane 28B-28B, respectively, of a fifth embodiment, device 600assembled with upper housing 201 and further coupled with male Luerdevice 650. Device 600 demonstrates how slit 217 of elastomeric member210 can accommodate medical device 675 inserted through catheter 602 a,guided by tapered internal conduit 602 e.

FIGS. 29A and 29B are a perspective view and cross-sectional view alongsectional plane 29B-29B, respectively, of a sixth embodiment, device700. Device 700 demonstrates the pressure activated valve of the presentdisclosure integrated directly with luer-activated valve 701. Thepressure activated valve assembly is joined to the luer activated valveassembly at 727. Luer activated valve 701 is assembled into female luerhousing 703 and is sealed within it at 728. Device 700 comprising Lueractivated valve as shown is an example of one valve, however thepressure activated valve assembly can be integrated with any number ofluer activated valves to provide for the benefits as disclosed herein.

FIGS. 30A and 30B, 31A and 31B show another embodiment according to theinvention in an explosive view similar to the view according to FIG. 4.The difference is that the needle includes slightly proximal from theneedle feature 25 a through-hole formed as a slit 70. The slit 70extends in transverse direction to the longitudinal axis A of theneedle. The slit 70 provides a flashback feature as described in theintroductory part of the description.

It is to be added that in regard to the present invention of differentembodiments of a safety IV catheter having a needle guard 32 as well apressure activated valve according to the description of the valvedevice with reference to FIGS. 11 to 29, the upper housing 101, 201, 701can be formed by the proximal catheter hub portion 12 ₁ and the lowerhousing 102, 202, 302, 402, 502, 602, can be formed by the distalcatheter hub portion 12 ₂. It is also possible to combine a separatevalve device as described e.g. in regard to FIG. 11 with the safety IVcatheter, which is still covered by the invention.

FIGS. 32A and 32B show yet another embodiment of the invention. Thedifference is that a port 71 extends from the main body of the catheterhub 12 ₁ in a direction generally perpendicular to the axial directionA. A cap 73 is provided to cover the port 71. Wings 72 are provided atthe main body opposite from the port 71.

It will be understood that, although the terms first, second, etc. maybe used herein to describe various elements, these elements should notbe limited by these terms. These terms are only used to distinguish oneelement from another. For example, a first element could be termed asecond element, and, similarly, a second element could be termed a firstelement, without departing from the scope of the present disclosure. Asused herein, the term “and/or” includes any and all combinations of oneor more of the associated' listed items.

Relative terms such as “below” or “above” or “upper” or “lower” or“horizontal” or “vertical” may be used herein to describe a relationshipof one element, layer or region to another element, layer or region asillustrated in the figures. It will be understood that these terms areintended to encompass different orientations of the device in additionto the orientation depicted in the figures.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the presentdisclosure. As used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise.

It will be further understood that the terms “comprises” “comprising,”“includes” and/or “including” when used herein, specify the presence ofstated features, integers, steps, operations, elements, and/orcomponents, but do not preclude the presence or addition of one or moreother features, integers, steps, operations, elements, components,and/or groups thereof

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this present disclosure belongs.It will be further understood that terms used herein should beinterpreted as having a meaning that is consistent with their meaning inthe context of this specification and the relevant art and will not beinterpreted in an idealized or overly formal sense unless expressly sodefined herein.

Unless otherwise expressly stated, comparative, quantitative terms suchas “less” and “greater”, are intended to encompass the concept ofequality. As an example, “less” can mean not only “less” in thestrictest mathematical sense, but also, “less than or equal to.” Theterm “fluid” as used herein refers to a liquid, gas, or combinationthereof.

1. An intravenous catheter apparatus comprising: a catheter hub (12)arranged at a proximal end of a catheter tube (10), the catheter hub(12) having an inner surface (14) defining a chamber (16); a needle (20)defining an axial direction and having a needle tip (24), the needle(20) extending through the chamber (16) and the catheter tube (10) whenin a ready position; a needle guard (32) slidably arranged on the needle(20) and at least partially received in the chamber (16) when the needle(20) is in the ready position, the needle guard (32) including a baseportion (34) and first and second arms (36, 38) extending from the baseportion (34), wherein the first arm (36) is deflected radially outwardsby the needle (20) against a restoring force when the needle (20) is inthe ready position whereby the needle guard (32) is brought intoretaining contact with the catheter hub (12); and wherein the catheterapparatus includes a valve which separates a distal space arranged indistal direction from the valve from a proximal space arranged onproximal direction from the valve, characterized that the valve opensbased on a pressure differential between the pressure prevailing in thedistal space and the pressure prevailing in the proximal space.
 2. Theintravenous catheter apparatus of claim 1, wherein the valve comprises:a housing having an first opening and a second opening; and anelastomeric member positioned in the housing, the elastomeric membercomprising a continuous peripheral wall projecting from a surface; and aslit extending through the surface, a continuous portion of theperipheral wall creating a continuous sealable contact with the housingand partitioning the housing into an upper section and a lower section,the elastomeric member configured such that upon creating a pressuredifferential between the upper section and the lower section of thehousing causes either: (i) the peripheral wall to deflect from thehousing permitting fluid flow around the elastomeric member; or (ii) theslit to open permitting fluid flow through the elastomeric member. 3.The intravenous catheter apparatus of claim 2, wherein, furthercomprising a support member positioned in the housing and surrounded bythe peripheral wall, the support configured to provide fluidcommunication between the first opening and the second opening.
 4. Theintravenous catheter apparatus of claim 2 or 3, wherein the supportmember is received by or integral with the housing.
 5. The intravenouscatheter apparatus of any one of claims 2 to 4, wherein the supportmember comprises a plurality of spaced apart columns arranged about thesecond opening, the distal ends of the plurality of columns surroundedby the peripheral wall.
 6. The intravenous catheter apparatus of any oneof claims 2 to 5, wherein the support member comprises an annular wallarranged around the second opening, the annular wall having at least onefluid flow passage providing fluid communication between the lowersection and the second opening.
 7. The intravenous catheter apparatus ofany one of claims 2 to 7, wherein the second opening comprises a conduitthat extends into the housing and is surrounded the peripheral wall. 8.The intravenous catheter apparatus of claim 7, wherein a portion of theconduit extending into the housing is of a larger internal diameter thanthe conduit extending external to the housing.
 9. The intravenouscatheter apparatus of any one of claims 2 to 8, wherein a portion ofhousing is tapered and a distal portion of the peripheral wall tapers insealable contact therewith.
 10. The intravenous catheter apparatus ofany one of claims 2 to 9, wherein the upper portion of the housingcomprises an interior wall, the interior wall comprising at least onerecessed channel therein and extending substantially along thelongitudinal axis of the housing, wherein deflection of the peripheralwall from the housing substantially corresponds to the placement of theat least one recessed channel.
 11. The intravenous catheter apparatus ofany one of claims 2 to 10, wherein the surface comprises a top surfaceand a bottom surface separated from the top surface by a firstthickness; and the peripheral wall has a second thickness, and theperipheral wall projects from the bottom surface, wherein optionally thesecond thickness is less than the first thickness.
 12. The intravenouscatheter apparatus of any one of claims 2 to 11, wherein the elastomericmember further comprises a continuous lateral protrusion along theperipheral edge of the surface, and the housing is configured with acorresponding recess to receive the continuous lateral protrusion and toprovide a radial stress to the surface of the elastomeric member. 13.The intravenous catheter apparatus of any one of claims 2 to 12, whereinthe elastomeric member further comprises one or more verticalprotrusions on the top surface, the housing being configured to providea normal stress to the one or more vertical protrusions.
 14. Theintravenous catheter apparatus of any one of claims 2 to 13, wherein theelastomeric member is concave, convex, or concave and convex on opposingsides of the thickness.
 15. The intravenous catheter apparatus of anyone of claims 2 to 14, wherein the top surface of the elastomeric memberhas one or more fluid channels terminating at the peripheral edge. 16.The intravenous catheter apparatus of any one of claims 2 to 15, whereinthe elastomeric member is annular, oval, cylindrical, hemispherical,cup-shaped or conical frustum-shaped.
 17. The intravenous catheterapparatus of any one of claims 2 to 16, wherein the slit opens at athreshold pressure greater than a threshold pressure required to deflectthe peripheral wall from the housing.
 18. The intravenous catheterapparatus of any one of claims 2 to 17, wherein the slit, in combinationwith the first opening and the second opening, is configured to receivethe needle through the housing.
 19. The intravenous catheter apparatusof any one of claims 2 to 18, wherein the support is configured toreceive and/or guide the needle through the housing.
 20. The intravenouscatheter apparatus of any one of claims 2 to 19, wherein the support incombination with the slit is configured to receive and/or guide theneedle through the housing.
 21. The intravenous catheter apparatus ofany one of claims 2 to 20, wherein the housing of the valve is formed asa separate component or wherein the housing is part of the catheter hub.22. The intravenous catheter apparatus of any one of the precedingclaims, wherein the catheter hub is formed by at least two components,comprising a distal catheter hub portion holding the catheter tube, anda proximal catheter hub portion, wherein the at least two components aremounted to one another.
 23. The intravenous catheter apparatus of claim22, wherein one of the distal catheter hub portion and the proximalcatheter hub portion includes a female connecting section and whereinthe other of the distal catheter hub portion and the proximal catheterhub portion includes a male connecting section fitting into the femaleconnecting section.
 24. The intravenous catheter apparatus of claim 23,wherein the male connecting section and/or the female connecting sectionare formed with a thread or a snap-fit arrangement fitting into oneanother.
 25. The intravenous catheter apparatus of any of claims 22 to24, wherein the proximal catheter hub portion includes a first proximalcatheter hub wall forming said chamber.
 26. The intravenous catheterapparatus of any of claim 22 or 25 and one of claims 2 to 21, whereinthe elastomeric member is arranged in an internal space formed by thedistal catheter hub portion or by the proximal catheter hub portion orby the distal and the proximal catheter hub portion.
 27. The intravenouscatheter apparatus of claim 26, wherein the support member is formed asa separate element or integrally formed either with the distal catheterhub portion or the proximal catheter hub portion.
 28. The intravenouscatheter apparatus of any one of the preceding claims, wherein thesecond arm (38) can be deflected radially inwards when the needle tip(24) is received between the arms (36, 38).
 29. The intravenous catheterapparatus of any one of the preceding claims, wherein the first andsecond arms (36, 38) are made of a resilient material.
 30. Theintravenous catheter apparatus of any one of the preceding claims,wherein the first and second arms (36, 38) are made of a plasticmaterial.
 31. The intravenous catheter apparatus of any one of thepreceding claims, wherein the first and second arms (36, 38) areintegrally formed with the base portion (34).
 32. The intravenouscatheter apparatus of any one of the preceding claims, wherein therestoring force is created by at least one of an elastic property of thefirst arm (36) and an additional tension element at least partlysurrounding the arms (36, 38).
 33. The intravenous catheter apparatus ofany one of the preceding claims, wherein the first arm (36) is longerthan the second arm (38).
 34. The intravenous catheter apparatus of anyone of the preceding claims, wherein the first arm (36) has a distal endsection (50) having an undercut (51) for catching the needle tip (24).35. The intravenous catheter apparatus according to claim 30, whereinthe distal end section (50) is angled towards the second arm (38) andoverlaps the second arm (38).
 36. The intravenous catheter apparatus ofany one of the preceding claims, further comprising retaining means forretaining the needle guard (32) in the chamber (16) as long as the firstarm (36) is in its deflected state, the retaining means including afirst disc-like retaining protrusion (58) provided on the first arm (36)and a retaining depression (18) formed in the inner surface (14) andadapted to receive the retaining protrusion (58).
 37. The intravenouscatheter apparatus of claim 36, wherein the retaining protrusion (58)has generally parallel proximal and distal faces (60, 62) and/or aconvex, in particular part-cylindrical, peripheral surface (64).
 38. Theintravenous catheter apparatus of any one of claim 36 or 37, wherein asecond disk-like retaining protrusion (66) is arranged on the second arm(38) and adapted to engage with the retaining depression (18).
 39. Theintravenous catheter apparatus of any one of claims 36 to 38, whereinthe needle guard (32) comprises a tension element at least partlysurrounding the arms (36, 38) in a region proximal of the firstretaining protrusion (58) or applying a linear biasing force biasing thearms (36, 38) together.
 40. The intravenous catheter according to one ofthe preceding claims, wherein the needle includes an opening closed theneedle tip, wherein the distance between the needle tip and the openingis arranged such that the opening is covered by the catheter hub whenthe needle is in the ready position.
 41. The intravenous catheteraccording to claim 40, wherein the opening is formed by a longitudinalslit extending with its longitudinal direction in parallel with ortransverse to a longitudinal axis of the needle.
 42. The intravenouscatheter according to one of the preceding claims, wherein the needleincludes a needle feature close to its needle tip changing thecross-sectional shape of the needle.
 43. The intravenous catheteraccording to claim 42, wherein the needle guard includes an opening witha predetermined diameter interacting with the needle feature such thatit prevents the retraction of the needle out of the needle guard whenthe needle is in the retracted position.
 44. The intravenous catheteraccording to claim 43, wherein the opening of the needle guardinteracting with the needle feature is integrally formed in the needleguard or formed by an a metal or plastic washer.